Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy with Perfusion Index (PI)

NCT06203743 | Completed DMC

• 1 other identifier: BYIEAH-AKD-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, randomised, controlled double-blind clinical trial. The primary aim was to evaluate the efficacy of caudal block and ilioinguinal-iliohypogastric nerve block with PI and PVI in pediatric inguinal hernia operations under general anesthesia. The secondary aim is to evaluate postoperative analgesic agent consumption and to evaluate the correlation of PI and PVI values with hemodynamic parameters. Pediatric patients between the ages of 2-8 years who are planned to undergo elective inguinal hernia operation will be included in the study. After the patients scheduled for inguinal hernia surgery are admitted to the operating room, routine monitoring will be performed as performed. In addition to routine monitoring, a Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe will be attached to the toe to monitor PI and PVI. Patients will be given anaesthetic drugs as routinely administered. After LMA by randomisation by closed envelope method, caudal or ilioinguinal-iliohypogastric nerve block will be performed by an experienced anaesthetist as the investigators routinely perform in patients other than the control group.. PI, PVI, pulse, saturation, noninvasive arterial pressure values will be recorded before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) at 0, 5, 10, 15, 20, 25 and 30 minutes and at the end of anaesthesia. All patients will be given paracetamol 10mg/kg iv, which is a routine intravenous (iv) analgesic, at the end of surgery. In case of perioperative complications, the complications will be recorded. Flacc pain scale (Face, Legs, Activity, Cry, Consolability) will be applied at 0, 2, 6 hours postoperatively. Postoperative analgesic use and discharge time will be recorded. Flacc pain scale will be performed by an anaesthetist blinded to the study.

Conditions

Perfusion Index; Plethysmography; Anesthesia, Caudal; Nerve Block; Anesthesia, Regional; Child; Inguinal Hernia Unilateral

Keywords

Perfusion Index; plethysmography variability index; caudal block; ilioinguinal iliohypogastric nerve block; nerve block; Inguinal hernia

Outcome Measures

Primary Outcomes (1)

• PI and PVI

  PI and PVI will be measured using a Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe. PI, PVI and hemodynamic data will be used to evaluate the efficacy of the blocks and the pain status of the patients.

  during the operation

Secondary Outcomes (3)

• FLACC pain scale

  up to six hour

• Analgesic use

  1 day

• Duration of discharge

  1 day

Study Arms (3)

control group

NO INTERVENTION

Patients in this group will not undergo any block after LMA. PI, PVI, pulse, saturation, noninvasive arterial pressure values will be recorded before induction, after induction, after LMA, at 0, 5, 10, 15, 20, 25 and 30 minutes after the surgical incision and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

caudal block group

ACTIVE COMPARATOR

Patients in this group will receive a caudal block in the lateral decubitus position after LMA with 0.25% Buvasin® 0.5ml/kg. PI, PVI, pulse, saturation, noninvasive arterial pressure values before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) 0., 5., 10., 15., 20., 25. It will be recorded at the 30th and 30th minutes and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

Procedure: caudal block group

ilioinguinal-iliohypogastric nerve block group

ACTIVE COMPARATOR

Patients in this group will undergo an ilioinguinal-iliohypogastric nerve block in the supine position under ultrasound guidance after LMA with 0.25% Buvasin® 0.5ml/kg. PI, PVI, pulse, saturation, noninvasive arterial pressure values before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) 0., 5., 10., 15., 20., 25. It will be recorded at the 30th and 30th minutes and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

Procedure: ilioinguinal-iliohypogastric nerve block group

Interventions

caudal block group PROCEDURE

PI, PVI measurements and hemodynamic data will be compared between groups

caudal block group

ilioinguinal-iliohypogastric nerve block group PROCEDURE

PI, PVI measurements and hemodynamic data will be compared between groups

ilioinguinal-iliohypogastric nerve block group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Elective Inguinal hernia operation
• ASA I-II patients

You may not qualify if:

• \<2 years to be \>8 years old
• ASA III-IV patients
• Peripheral vascular disease
• Diabetes Mellitus patient
• Neuromuscular disease
• Bleeding disorder
• Infection in the area to be blocked
• Infection at the perfusion index probe adhesion site
• Bilateral inguinal hernia operation
• Inguinal hernia operation with circumcision
• Cases taken to emergency operation
• Mental retardation
• Not knowing Turkish
• Allergy to local anesthetics
• Refusal to participate in the research

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Aycan Kurtarangil Doğan

  akurtarangil@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study randomization will be done in sealed envelopes using computer-generated randomization codes by a doctor who will not participate in patient follow-up. For the quality and standardization of the block with bupivacain, the caudal and ilioinguinal-iliohypogastric block will be performed by an anesthetist experienced in regional anesthesia. Postoperative Flacc pain scale, type and amount of additional analgesic will be recorded by a doctor blinded to the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of anesthesiology and reanimation

Model Details: The research is a prospective controlled, randomized, double-blind study

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 12, 2024
• Study Start: January 18, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)